Product code EKM
- Device name
- Gutta-Percha
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3850
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 |
| K070246 | DOWN PAK | Endo Twinn B.V. | 2007-02-16 |
| K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. | 2006-06-26 |
| K042870 | ENDO TWINN | Endo Twinn B.V. | 2005-01-11 |
| K023819 | FIBERFILL SGP | Pentron Clinical Technologies | 2003-03-26 |
| K971641 | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. | 1997-07-21 |
| K970134 | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | 1997-03-21 |
| K931742 | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. | 1993-05-27 |
| K924825 | MICRODOSE RC-EZ | Unicep | 1993-03-05 |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | 1992-01-21 |
| K910224 | THERMAPREP | Tulsa Dental Products, Ltd. | 1991-03-29 |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1990-11-13 |
| K896663 | ENDO-PREP | Pulpdent Corp. | 1990-02-14 |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1988-04-07 |
| K863411 | GUTTA PERCHA | Endodent, Inc. | 1986-10-30 |
| K863638 | GUTTA PERCHA POINTS | Endodent, Inc. | 1986-10-30 |
| K862129 | SET CANAL SEALER PASTE | Endo Technic Corp. | 1986-07-22 |
| K850863 | ULTRAFIL-LT (GUTTA PERCHA) | The Hygenic Corp. | 1985-04-16 |
| K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | 1983-09-26 |
| K830114 | GUTTA PERCHA POINTS | North Pacific Dental, Inc. | 1983-03-01 |
| K830115 | PAPER POINTS | North Pacific Dental, Inc. | 1983-03-01 |
| K823486 | TOUCH-N-HEAT MODEL 5001 | Analytic Technology | 1983-01-18 |
| K820639 | OBTURATION SYSTEM KIT | U.S. Shizai Corp. | 1982-04-09 |
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|---|---|---|---|
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| 08800069202962 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202955 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202948 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202931 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202924 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202917 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202900 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202894 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202887 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202870 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202863 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202856 | Bassi | SURE DENT CORPORATION | 2022-10-18 |
| 08800069202689 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202535 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202672 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202665 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202658 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202641 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202634 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202627 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202610 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202603 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202597 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202580 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202573 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202566 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202559 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202542 | Minikut | SURE DENT CORPORATION | 2022-09-07 |